Ignite Creation Date:
2025-12-24 @ 5:53 PM
Ignite Modification Date:
2026-02-18 @ 11:37 PM
Study NCT ID:
NCT03119168
Status:
COMPLETED
Last Update Posted:
2019-06-05
First Post:
2017-04-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of Simethicone on Screening Colonoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D012841', 'term': 'Simethicone'}, {'id': 'C557319', 'term': 'alginate-polyethylene glycol acrylate'}], 'ancestors': [{'id': 'D004129', 'term': 'Dimethylpolysiloxanes'}, {'id': 'D012828', 'term': 'Silicones'}, {'id': 'D012833', 'term': 'Siloxanes'}, {'id': 'D017646', 'term': 'Organosilicon Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D001697', 'term': 'Biomedical and Dental Materials'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'antonio.mendoza-ladd@ttuhsc.edu', 'phone': '915-215-4678', 'title': 'The Effect Of Adding High Dose Simethicone To A Standard Polyethylene Glycol Preparation On Adenoma', 'organization': 'Texas Tech University Health Sciences Center at El Paso'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'The study was done at our hospital setting, generalizability can be examined in larger studies'}}, 'adverseEventsModule': {'timeFrame': '60 minutes', 'eventGroups': [{'id': 'EG000', 'title': 'Simethicone Solution + Polyethylenglycol', 'description': 'Simethicone solution + Polyethylenglycol were received as a bowel prep regimen', 'otherNumAtRisk': 129, 'deathsNumAtRisk': 129, 'otherNumAffected': 0, 'seriousNumAtRisk': 129, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Polyethylenglycol', 'description': 'Polyethylenglycol was received as a bowel prep regimen', 'otherNumAtRisk': 139, 'deathsNumAtRisk': 139, 'otherNumAffected': 0, 'seriousNumAtRisk': 139, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Adenoma Detection Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Simethicone Solution + Polyethylenglycol', 'description': 'This arm of the study will include the patients assigned to take simethicone solution with their colon preparations\n\nSimethicone Solution: Patients will be assigned randomly to take Simethicone Solution plus polyethylenglycol'}, {'id': 'OG001', 'title': 'Polyethylenglycol', 'description': 'This arm of the study will include the patients assigned to take a regular bowel preparation with Polyethylenglycol\n\nPolyethylenglycol: Patients in this arm will be randomly assigned to take polyethylenglycol as their regular bowel preparation'}], 'classes': [{'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '25 minutes', 'description': 'The number of adenomatous polyps removed at colonoscopy', 'unitOfMeasure': 'adenomas', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Withdrawal Times', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Simethicone Solution + Polyethylenglycol', 'description': 'This arm of the study will include the patients assigned to take simethicone solution with their colon preparations\n\nSimethicone Solution: Patients will be assigned randomly to take Simethicone Solution plus polyethylenglycol'}, {'id': 'OG001', 'title': 'Polyethylenglycol', 'description': 'This arm of the study will include the patients assigned to take a regular bowel preparation with Polyethylenglycol\n\nPolyethylenglycol: Patients in this arm will be randomly assigned to take polyethylenglycol as their regular bowel preparation'}], 'classes': [{'categories': [{'measurements': [{'value': '395.7', 'spread': '69.2', 'groupId': 'OG000'}, {'value': '399', 'spread': '76.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6-10 minutes', 'description': 'Amount spent withdrawing the scope during the colonoscopy', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Colon Preparation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Simethicone Solution + Polyethylenglycol', 'description': 'This arm of the study will include the patients assigned to take simethicone solution with their colon preparations\n\nSimethicone Solution: Patients will be assigned randomly to take Simethicone Solution plus polyethylenglycol'}, {'id': 'OG001', 'title': 'Polyethylenglycol', 'description': 'This arm of the study will include the patients assigned to take a regular bowel preparation with Polyethylenglycol\n\nPolyethylenglycol: Patients in this arm will be randomly assigned to take polyethylenglycol as their regular bowel preparation'}], 'classes': [{'title': 'Boston Bowel Preparation Scale', 'categories': [{'measurements': [{'value': '8.9', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '8.9', 'spread': '0.4', 'groupId': 'OG001'}]}]}, {'title': 'Bubble Scale', 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '2.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '25 minutes', 'description': 'Boston Bowel Preparation Scale (BBPS): scale that rates the quality of the colon preparation based on the amount of stool present. 0:solid stool that cannot be cleared; 1:areas not well seen due to residual stool and/or opaque liquid; 2:small fragments of stool and/or opaque liquid, but mucosa seen well; 3:no residual stool or opaque liquid seen. Score determined by adding the score of each individual segment of the colon (right side, transverse and left side). Scores range from 0 to 3 in each segment, therefore, a total composite score ranges from 0 (poor) to 9 (excellent).\n\nBubble Score (BS): scale that rates the amount of bubbles present in the colon. 0:no or minimal bubbles; 1:bubbles covering up to half the luminal diameter; 2:bubbles covering the circumference of the lumen; 3:bubbles filling the entire lumen. Score determined the same way as BBPS score but in this case a total score of 0 is excellent and 9 is poor.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Intraprocedural Use of Simethicone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Simethicone Solution + Polyethylenglycol', 'description': 'The number of colonoscopies during which the endoscopist requested simethicone to be flushed through the endoscope'}, {'id': 'OG001', 'title': 'Polyethylenglycol', 'description': 'The number of colonoscopies during which the endoscopist requested simethicone to be flushed through the endoscope'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6-10 minutes', 'description': 'The number of colonoscopies during which the endoscopist requested simethicone to be flushed through the endoscope.', 'unitOfMeasure': 'colonoscopies', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Simethicone Solution + Polyethylenglycol', 'description': 'This arm of the study will include the patients assigned to take simethicone solution with their colon preparation (4L Polyethylenglycol)\n\nSimethicone Solution: Patients will be assigned randomly to take Simethicone Solution plus 4 L of polyethylenglycol'}, {'id': 'FG001', 'title': 'Polyethylenglycol', 'description': 'This arm of the study will include the patients assigned to take a regular bowel preparation with 4L Polyethylenglycol\n\nPolyethylenglycol: All patients were assigned to take 4L polyethylenglycol as their regular bowel preparation'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '129'}, {'groupId': 'FG001', 'numSubjects': '139'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '129'}, {'groupId': 'FG001', 'numSubjects': '139'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'BG000'}, {'value': '139', 'groupId': 'BG001'}, {'value': '268', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Simethicone Solution + Polyethylenglycol', 'description': 'This arm of the study will include the patients assigned to take simethicone solution with their colon preparations\n\nSimethicone Solution: Patients will be assigned randomly to take Simethicone Solution plus polyethylenglycol'}, {'id': 'BG001', 'title': 'Polyethylenglycol', 'description': 'This arm of the study will include the patients assigned to take a regular bowel preparation with Polyethylenglycol\n\nPolyethylenglycol: Patients in this arm will be randomly assigned to take polyethylenglycol as their regular bowel preparation'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.3', 'spread': '7.55', 'groupId': 'BG000'}, {'value': '57', 'spread': '6.02', 'groupId': 'BG001'}, {'value': '57', 'spread': '6.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '81', 'groupId': 'BG000'}, {'value': '92', 'groupId': 'BG001'}, {'value': '173', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '95', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Hispanic', 'categories': [{'measurements': [{'value': '111', 'groupId': 'BG000'}, {'value': '124', 'groupId': 'BG001'}, {'value': '235', 'groupId': 'BG002'}]}]}, {'title': 'Non Hispanic', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '129', 'groupId': 'BG000'}, {'value': '139', 'groupId': 'BG001'}, {'value': '268', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Count of participants', 'classes': [{'categories': [{'measurements': [{'value': '129', 'groupId': 'BG000'}, {'value': '139', 'groupId': 'BG001'}, {'value': '268', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-01-10', 'size': 528267, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-04-18T14:31', 'hasProtocol': True}, {'date': '2018-08-02', 'size': 401439, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2019-04-18T14:32', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 268}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2019-04-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-03', 'studyFirstSubmitDate': '2017-04-10', 'resultsFirstSubmitDate': '2019-04-18', 'studyFirstSubmitQcDate': '2017-04-13', 'lastUpdatePostDateStruct': {'date': '2019-06-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-06-03', 'studyFirstPostDateStruct': {'date': '2017-04-18', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-06-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adenoma Detection Rate', 'timeFrame': '25 minutes', 'description': 'The number of adenomatous polyps removed at colonoscopy'}], 'secondaryOutcomes': [{'measure': 'Withdrawal Times', 'timeFrame': '6-10 minutes', 'description': 'Amount spent withdrawing the scope during the colonoscopy'}, {'measure': 'Colon Preparation', 'timeFrame': '25 minutes', 'description': 'Boston Bowel Preparation Scale (BBPS): scale that rates the quality of the colon preparation based on the amount of stool present. 0:solid stool that cannot be cleared; 1:areas not well seen due to residual stool and/or opaque liquid; 2:small fragments of stool and/or opaque liquid, but mucosa seen well; 3:no residual stool or opaque liquid seen. Score determined by adding the score of each individual segment of the colon (right side, transverse and left side). Scores range from 0 to 3 in each segment, therefore, a total composite score ranges from 0 (poor) to 9 (excellent).\n\nBubble Score (BS): scale that rates the amount of bubbles present in the colon. 0:no or minimal bubbles; 1:bubbles covering up to half the luminal diameter; 2:bubbles covering the circumference of the lumen; 3:bubbles filling the entire lumen. Score determined the same way as BBPS score but in this case a total score of 0 is excellent and 9 is poor.'}, {'measure': 'Intraprocedural Use of Simethicone', 'timeFrame': '6-10 minutes', 'description': 'The number of colonoscopies during which the endoscopist requested simethicone to be flushed through the endoscope.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['screening', 'adenoma detection rate', 'simethicone'], 'conditions': ['Adenoma Colon']}, 'referencesModule': {'references': [{'pmid': '19950784', 'type': 'BACKGROUND', 'citation': 'Park JJ, Lee SK, Jang JY, Kim HJ, Kim NH. The effectiveness of simethicone in improving visibility during colonoscopy. Hepatogastroenterology. 2009 Sep-Oct;56(94-95):1321-5.'}, {'pmid': '27428209', 'type': 'BACKGROUND', 'citation': 'Yoo IK, Jeen YT, Kang SH, Lee JH, Kim SH, Lee JM, Choi HS, Kim ES, Keum B, Chun HJ, Lee HS, Kim CD. Improving of bowel cleansing effect for polyethylene glycol with ascorbic acid using simethicone: A randomized controlled trial. Medicine (Baltimore). 2016 Jul;95(28):e4163. doi: 10.1097/MD.0000000000004163.'}, {'pmid': '16564908', 'type': 'RESULT', 'citation': 'Rex DK, Petrini JL, Baron TH, Chak A, Cohen J, Deal SE, Hoffman B, Jacobson BC, Mergener K, Petersen BT, Safdi MA, Faigel DO, Pike IM. Quality indicators for colonoscopy. Gastrointest Endosc. 2006 Apr;63(4 Suppl):S16-28. doi: 10.1016/j.gie.2006.02.021. No abstract available.'}, {'pmid': '22239959', 'type': 'RESULT', 'citation': 'Hassan C, Fuccio L, Bruno M, Pagano N, Spada C, Carrara S, Giordanino C, Rondonotti E, Curcio G, Dulbecco P, Fabbri C, Della Casa D, Maiero S, Simone A, Iacopini F, Feliciangeli G, Manes G, Rinaldi A, Zullo A, Rogai F, Repici A. A predictive model identifies patients most likely to have inadequate bowel preparation for colonoscopy. Clin Gastroenterol Hepatol. 2012 May;10(5):501-6. doi: 10.1016/j.cgh.2011.12.037. Epub 2012 Jan 10.'}, {'pmid': '30926430', 'type': 'DERIVED', 'citation': 'Moraveji S, Casner N, Bashashati M, Garcia C, Dwivedi A, Zuckerman MJ, Carrion A, Ladd AM. The role of oral simethicone on the adenoma detection rate and other quality indicators of screening colonoscopy: a randomized, controlled, observer-blinded clinical trial. Gastrointest Endosc. 2019 Jul;90(1):141-149. doi: 10.1016/j.gie.2019.03.018. Epub 2019 Mar 26.'}]}, 'descriptionModule': {'briefSummary': 'This study is evaluating the effect of adding a high dose of simethicone to the standard polyethylene glycol preparation for screening colonoscopy in the quality of the preparation , adenoma detection rate and withdrawal times.', 'detailedDescription': "A proper bowel preparation is key to a thorough and safe colonoscopy. Several factors affect the mucosal visualization during colonoscopy, and consequently the quality of such evaluation. Undoubtedly, this can have unfavorable implications like missed lesions. One of the most commonly encountered scenarios is the presence of multiple bubbles that interfere with mucosal visualization. When this occurs, simethicone (an antifoam agent used to reduce bloating when ingested orally) is injected through the colonoscope to eliminate the bubbles and get a clear view of the mucosa. A few studies have used oral simethicone in conjunction with oral preparation agents (PEG, magnesium citrate, sodium phosphate) in an attempt to improve the quality of the preparation. Unfortunately these studies have not used the exact same preparation agent with and without simethicone, making it difficult to draw conclusions on its efficacy. However, it is important to understand that simethicone is not intended to decrease the amount of stool in the colon, and it's purpose is to decrease the amount of bubbles interfering with the visualization of the mucosa provided that there is no stool present . Furthermore, it is unclear if adding simethicone to a standard bowel preparation makes a significant difference in key aspects of screening colonoscopy such as adenoma detection rate or withdrawal times. This prospective randomized controlled, observer blinded study at Texas Tech University Health Sciences Center in El Paso, aims at studying the effect of simethicone on the overall colon preparation as well as on adenoma detection rate and withdrawal times."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients between the ages of 30-80 scheduled for screening colonoscopy.\n2. Male and female patients\n3. Ambulatory patients\n4. Signed informed consent form\n\nExclusion Criteria:\n\n1. Previous colonic surgery\n2. Patient with mental/physical condition that impairs oral ingestion of preparation\n3. Allergy or hypersensitivity to simethicone\n4. Patients with limited mobility (bedridden patients)\n5. Patients with gastrointestinal obstruction\n6. Patients with gastroparesis'}, 'identificationModule': {'nctId': 'NCT03119168', 'briefTitle': 'Effect of Simethicone on Screening Colonoscopy', 'organization': {'class': 'OTHER', 'fullName': 'Texas Tech University Health Sciences Center, El Paso'}, 'officialTitle': 'The Effect Of Adding High Dose Simethicone To A Standard Polyethylene Glycol Preparation On Adenoma Detection Rate During Screening Colonoscopy: A Randomized Controlled Pilot Trial', 'orgStudyIdInfo': {'id': 'E17034'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Simethicone solution + Polyethylenglycol', 'description': 'This arm of the study will include the patients assigned to take simethicone solution with their colon preparations ( 4L Polyethyleneglycol)', 'interventionNames': ['Drug: Simethicone Solution']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Polyethylenglycol', 'description': 'This arm of the study will include the patients assigned to take a regular bowel preparation (4L Polyethylenglycol)', 'interventionNames': ['Other: Polyethylenglycol']}], 'interventions': [{'name': 'Simethicone Solution', 'type': 'DRUG', 'otherNames': ['mylicon'], 'description': 'Patients will be assigned randomly to take Simethicone Solution plus polyethylenglycol', 'armGroupLabels': ['Simethicone solution + Polyethylenglycol']}, {'name': 'Polyethylenglycol', 'type': 'OTHER', 'description': 'Patients in this arm will be randomly assigned to take polyethylenglycol as their regular bowel preparation', 'armGroupLabels': ['Polyethylenglycol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '79905', 'city': 'El Paso', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Tech university Health Sciences Center El Paso', 'geoPoint': {'lat': 31.75872, 'lon': -106.48693}}], 'overallOfficials': [{'name': 'Antonio H Mendoza-Ladd, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Texas Tech University Health Sciences Center, El Paso'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Texas Tech University Health Sciences Center, El Paso', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Medicine', 'investigatorFullName': 'Antonio Mendoza-Ladd', 'investigatorAffiliation': 'Texas Tech University Health Sciences Center, El Paso'}}}}